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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 3501
Device Problems Signal Artifact/Noise (1036); Fracture (1260); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Material Integrity Problem (2978)
Patient Problem Electric Shock (2554)
Event Date 12/05/2023
Event Type  Injury  
Event Description
It was reported that the patient received an inappropriate shock from the subcutaneous implantable cardioverter defibrillator (s-icd) due to oversensing of noise.The patient was brought into the office for follow-up where the noise was able to be recreated in all three sensing vectors.Electrode damage is thought to be the cause of the noise.The physician is considering a revision procedure, however, to date no intervention has occurred.The field representative is unaware of any scheduled interventions.The electrode and s-icd remain in service and no adverse effects were reported.
 
Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.
 
Event Description
It was reported that the patient received an inappropriate shock from the subcutaneous implantable cardioverter defibrillator (s-icd) due to oversensing of noise.The patient was brought into the office for follow-up where the noise was able to be recreated in all three sensing vectors.Electrode damage is thought to be the cause of the noise.The physician is considering a revision procedure, however, to date no intervention has occurred.The field representative is unaware of any scheduled interventions.The electrode and s-icd remain in service and no adverse effects were reported.Further review found that previous x-rays showed a strong bending in the electrode.Additional information was received that the electrode and s-icd were both explanted as during the procedure no electrode damage was present.It was noted neither of the products are expected to be returned as they were disposed of by the hospital.
 
Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.It was noted neither of the products are expected to be returned as they were disposed of by the hospital.
 
Event Description
It was reported that the patient received an inappropriate shock from the subcutaneous implantable cardioverter defibrillator (s-icd) due to oversensing of noise.The patient was brought into the office for follow-up where the noise was able to be recreated in all three sensing vectors.Electrode damage is thought to be the cause of the noise.The physician is considering a revision procedure, however, to date no intervention has occurred.The field representative is unaware of any scheduled interventions.The electrode and s-icd remain in service and no adverse effects were reported.Further review found that previous x-rays showed a strong bending in the electrode.Additional information was received that the electrode and s-icd were both explanted as during the procedure no electrode damage was present.It was noted neither of the products are expected to be returned as they were disposed of by the hospital.
 
Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.It was noted neither of the products are expected to be returned as they were disposed of by the hospital.This report is being filed to remove an impact code (h6) that was inadvertently entered on the last report.
 
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Brand Name
EMBLEM S-ICD
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
EI   00646-2602
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key18389285
MDR Text Key331378716
Report Number2124215-2023-73467
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P110042/S077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3501
Device Catalogue Number3501
Device Lot Number246816
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2023
Initial Date FDA Received12/22/2023
Supplement Dates Manufacturer Received01/24/2024
05/09/2024
Supplement Dates FDA Received02/16/2024
05/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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